| ENROUTE Transcarotid Neuroprotection System (K153485) | Silk Road Medical, Inc. | 2016-03-10 |
| Exactech Vantage Total Ankle System (K152217) | Exactech, Inc. | 2016-03-10 |
| Thora-3Di, Model T-01 (K151940) | Pneumacare Limited | 2016-03-10 |
| GuideWire (K160369) | Fiagon GmbH | 2016-03-10 |
| ReadeR, VieweR, QuickScan PSP (K160386) | Trident S.R.L | 2016-03-10 |
| Reprocessed Diagnostic Ultrasound Catheter (K153090) | Innovative Health, LLC | 2016-03-10 |
| OMNI Skirted Heads (K152919) | Omni Life Science, Inc. | 2016-03-10 |
| Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines (K151421) | Salter Labs | 2016-03-10 |
| QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (K142993) | Orion Diagnostica, OY | 2016-03-10 |
| Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color (K152720) | Xingda Medical Products Co., Ltd. | 2016-03-10 |
| Optetrak One Logic Femoral Components (K153776) | Exactech, Inc. | 2016-03-10 |
| Vivid T8 (K160078) | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L | 2016-03-10 |
| Sonoma Fibula Repair System (K160069) | Sonoma Orthopedics Products, Inc. | 2016-03-10 |
| Thommen Milling Abutment for CAD/CAM (K151984) | Thommen Medical AG | 2016-03-10 |
| Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712) | Zhonghong Pulin Medical Products Co., Ltd. | 2016-03-09 |
| Biomet Variable Pitch Compression Screw System (K160058) | Biomet, Inc. | 2016-03-09 |
| S-Wire (K152662) | Spinal Resources, Inc. | 2016-03-09 |
| Gammex PI Hybrid Surgical Gloves (K151694) | Ansell Healthcare Products, LLC | 2016-03-09 |
| Family of CoolGlide Aesthetic Lasers (K153671) | Cutera, Inc. | 2016-03-09 |
| da Vinci Single-Site Instrument and Accessories (K152448) | Intuitive Surgical, Inc. | 2016-03-09 |
| TE7 Diagnostic Ultrasound System (K160381) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-03-09 |
| SmartView 3D Option (K153429) | Ge Hangwei Medical System Co., Ltd. | 2016-03-09 |
| MMS Guide Catheter (K152625) | Micro Medical Solutions, Inc. | 2016-03-09 |
| Piccolo Composite(R) Distal Volar Radius Plate System (K160002) | CarboFix Orthopedics , Ltd. | 2016-03-09 |
| CharmFlex (K152766) | Dentkist, Inc. | 2016-03-08 |
| TruGuard Custom Tongue and Jaw Positioner (K153270) | Bionix Development Corp. | 2016-03-08 |
| Propeller System (K152882) | Reciprocal Labs | 2016-03-08 |
| Erisma-LP Spinal Fixation System (K153326) | Clariance, Sas | 2016-03-08 |
| Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System (K160085) | Zimmer GmbH | 2016-03-08 |
| SurgiPure XD Reconstructive Tissue Matrix (K152206) | Tissue Regenix Group Plc | 2016-03-08 |
| Mailuokang Self-adhesive Electrode (K152815) | Shenzhen Mailuokang Technology Co., Ltd. | 2016-03-08 |
| Ventix Knotless Anchors (K152262) | Biomet Manufacturing Corp | 2016-03-08 |
| ProLift Expandable System (K153400) | Life Spine, Inc. | 2016-03-07 |
| iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System (K160025) | Conformis, Inc. | 2016-03-07 |
| Medline Epidural Catheter (K150731) | Medline Industries, Inc. | 2016-03-07 |
| URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K152835) | Teco Diagnostics, Inc. | 2016-03-07 |
| MEDT PEN NEEDLE (K152824) | Shandong Caremed Medical Products Co., Ltd. | 2016-03-07 |
| PERIMETER Interbody Fusion Device (K160418) | Medtronic Sofamor Danek USA, Inc. | 2016-03-07 |
| Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select (K153430) | Cook Incorporated | 2016-03-07 |
| Xpert Carba-R (K152614) | Cepheid | 2016-03-07 |
| Cobbra RF Tissue Dissector (K160041) | Elliquence, LLC | 2016-03-07 |
| Cios Fusion (K153244) | Siemens Medical Solutions USA, Inc. | 2016-03-07 |
| Bead Block (K150876) | Biocompatibles UK , Ltd. | 2016-03-07 |
| VisuCon-F Low Fibrinogen Control Plasma (K150144) | Affinity Biologicals, Inc. | 2016-03-06 |
| Aquasil Ultra + Smart Wetting Impression Material (K152861) | Dentply International, Inc. | 2016-03-04 |
| Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5 (K152238) | Sun Capsule, Inc. | 2016-03-04 |
| ASAHI Corsair Armet (K152249) | Asahi Intecc Co., Ltd. | 2016-03-04 |
| Propeller Sensor Model 2014-R (K152482) | Reciprocal Labs | 2016-03-04 |
| Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory (K152897) | Integra LifeSciences Corporation | 2016-03-04 |
| Platinum dRF Imaging System (K160301) | Apelem-Dms Group | 2016-03-04 |
| IS4000 Stapler 30 Instrument and Stapler 30 Reloads (K152421) | Intuitive Surgical, Inc. | 2016-03-04 |
| PROTEK Duo 31 Fr. Veno-Venous Cannula Set (K160257) | Cardiacassist, Inc. | 2016-03-04 |
| Insufflator 50L FM134 (K153513) | W.O.M. World of Medicine GmbH | 2016-03-04 |
| IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) (K152402) | Securus,Inc | 2016-03-04 |
| LOCATOR F-Tx Attachment System (K151789) | Zest Anchors, LLC | 2016-03-04 |
| Cefaly (K160237) | Cefaly Technology | 2016-03-04 |
| DNAP Electrode (K152547) | Ad-Tech Medical Instrument Corporation | 2016-03-04 |
| MultiCross Catheter (K152957) | Roxwood Medical, Inc. | 2016-03-04 |
| SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens (K151847) | Smart Performer Corp. , Ltd. | 2016-03-04 |
| Endophys Pressure Sensing Sheath Kit (K160272) | Endophys, Inc. | 2016-03-04 |
| Straumann RN Gold Abutment for Bridge (K151590) | Straumann USA, LLC | 2016-03-04 |
| syngo.via MI Workflows (K160426) | Siemens Medical Solutions USA, Inc. | 2016-03-04 |
| Family of Steam Sterilizers B 28 series (K151597) | Cefla S.C. | 2016-03-04 |
| Sheathes Ultrasound Probe Covers (K153212) | Sheathing Technologies, Inc. | 2016-03-04 |
| syngo Application Software VD11 (K153346) | Siemens Medical Solutions USA, Inc. | 2016-03-04 |
| SENSIMED TRIGGERFISH (DEN140017) | Sensimed AG | 2016-03-04 |
| HARMONIC HOOK (K151136) | Ethicon Endo-Surgery, LLC | 2016-03-04 |
| ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) (K160276) | Instrumentation Laboratory CO | 2016-03-03 |
| Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (K153206) | Fujifilm Medical System U.S.A., Inc. | 2016-03-03 |
| Olea Sphere V3.0 (K152602) | Olea Medical | 2016-03-03 |
| Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (K160347) | Qingdao Hisense Medical Equipment Co., Ltd. | 2016-03-03 |
| Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film (K151123) | Pac-Dent International, Inc. | 2016-03-03 |
| GC Reline II (K153253) | GC America, Inc. | 2016-03-03 |
| Dunamis Force DFX Tensile Tape (K153746) | Dunamis, LLC | 2016-03-03 |
| Passport Series Patient Monitors (Including Passport 8, Passport 12) (K153448) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-03-03 |
| IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (K152061) | Siemens Healthcare Diagnostics, Inc. | 2016-03-03 |
| Tenex Health TX System (K153299) | Tenex Health, Inc. | 2016-03-03 |
| FULL CARE Disposable PVC Nelaton Catheter (K151745) | Shaoxing Fuqing Health Products Co., Ltd. | 2016-03-03 |
| Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020) | Captiva Spine | 2016-03-02 |
| Finger Type Pulse Oximeter (K151024) | Taidoc Technology Corporation | 2016-03-02 |
| Pencylcap (K152050) | B.Braun Melsungen AG | 2016-03-02 |
| PicoWay Laser System (K153527) | Syneron Candela Corporation | 2016-03-02 |
| Sentimag System, Sentimark Magnetic Marker Systerm (K153044) | Endomagnetics Ltd., | 2016-03-02 |
| RECON system - Compression Screws (K151708) | Normed Medizin-Technik GmbH | 2016-03-02 |
| Leksell Stereotactic System, Injection/ Aspiration Needle Kit (K152558) | Elekta Instrument AB | 2016-03-02 |
| BioPhotas Celluma3 (K152280) | Biophotas, Inc. | 2016-03-02 |
| Baha 5 Super Power Sound Processor (K153245) | Cochlear Americas | 2016-03-02 |
| PERIMETER C (Titanium) Spinal System (K153438) | Medtronic Sofamor Danek USA, Inc. | 2016-03-02 |
| Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 (K160241) | Olympus Medical Systems Corp. | 2016-03-02 |
| BEAUTIFIL II Gingiva (K151700) | Shofu Dental Corporation | 2016-03-02 |
| 3400E series; E5400 series; E6400 series; Sundazzler series (K151905) | Heartland Tanning, Inc. | 2016-03-01 |
| iFuse Implant System(R) (K152681) | SI-BONE, Inc. | 2016-03-01 |
| VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm (K160230) | Covidien | 2016-03-01 |
| xevonta dialyzer (K143482) | B. Braun Avitum AG | 2016-03-01 |
| SPINAUT-E, SPINAUT-I (K150789) | Imedicom Co., Ltd. | 2016-03-01 |
| Braun Thermoscan PRO 6000 Ear Thermometer (K152748) | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | 2016-03-01 |
| OrthAlign Plus System (K153237) | Orthalign, Inc. | 2016-03-01 |
| Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (K152719) | Xinfu Medical Products Co., Ltd. | 2016-03-01 |
| Wrist 3 (K160185) | Aspect Imaging, Ltd. | 2016-03-01 |
| Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (K153460) | Avinger, Inc. | 2016-03-01 |